国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
CLARITHROMYCIN (UNII: H1250JIK0A) (CLARITHROMYCIN - UNII:H1250JIK0A)
RedPharm Drug, Inc.
CLARITHROMYCIN
CLARITHROMYCIN 500 mg
ORAL
PRESCRIPTION DRUG
1.1 Acute Bacterial Exacerbation of Chronic Bronchitis Clarithromycin tablets, USP are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae[see Indications and Usage (1.9)] . 1.2 Acute Maxillary Sinusitis Clarithromycin tablets, USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae [see Indications and Usage (1.9)] . 1.3 Community-Acquired Pneumonia Clarithromycin tablets, USP are indicated [see Indications and Usage (1.9)] for the treatment of mild to moderate infections caused by susceptible isolates due to: Haemophilus influenzae (in adults) Mycoplasma pneumoniae, Streptococcus pneumoniae, Chlamydophila pneumoniae 1.4 Pharyngitis/Tonsillitis Clarithromycin tablets, USP are indicated for the treatment of mild to moderate
Clarithromycin tablets, USP are supplied as white to off-white oval film-coated tablets in the following packaging sizes: 250 mg tablets: (imprinted in blue with the “S39” on one side) Bottles of 60 ( NDC 0527-1931-06) 500 mg tablets: (debossed with the “S4” on one side) Bottles of 60 ( NDC 0527-1932-06) Store clarithromycin tablets, USP at controlled room temperature 20° to 25°C (68° to 77°F) in a well-closed container.
Abbreviated New Drug Application
CLARITHROMYCIN- CLARITHROMYCIN TABLET, FILM COATED REDPHARM DRUG, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CLARITHROMYCIN TABLETS, USP safely and effectively. See full prescribing information for CLARITHROMYCIN TABLETS, USP. Clarithromycin tablets USP, for oral use Initial U.S. Approval: 1991 RECENT MAJOR CHANGES Warnings and Precautions, Serious Adverse Reactions with Concomitant Use with Other Drugs (5.4) 10/2015 INDICATIONS AND USAGE Clarithromycin is a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults (1.1) Acute Maxillary Sinusitis (1.2) Community-Acquired Pneumonia (1.3) Pharyngitis/Tonsillitis (1.4) Uncomplicated Skin and Skin Structure Infections (1.5) Acute Otitis Media in Pediatric Patients (1.6) Treatment and Prophylaxis of Disseminated Mycobacterial Infections (1.7) Helicobacter pylori Infection and Duodenal Ulcer Disease in Adults (1.8) To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.9) DOSAGE AND ADMINISTRATION Adults: clarithromycin 250 mg or 500 mg every 12 hours for 7–14 days (2.2) H. pylori eradication (in combination with lansoprazole/amoxicillin, omeprazole/amoxicillin, or omeprazole): clarithromycin 500 mg every 8 or 12 hours for 10–14 days. See full prescribing information (FPI) for additional information. (2.3) Pediatric Patients: clarithromycin 15 mg/kg/day divided every 12 hours for 10 days (2.4) Mycobacterial Infections: clarithromycin 500 mg every 12 hours; clarithromycin 7.5 mg/kg up to 500 mg every 12 hours in pediatric patients (2.5) Reduce dose in moderate renal impairment with concomitant atazanavir or ritonavir- containing regimens and in severe rena 完全なドキュメントを読む